USFDA APPLICATION NUMBER - 20733 / DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
buprenorphine hydrochloride(UNII: 56W8MW3EN1) (buprenorphine - UNII:40D3SCR4GZ) | buprenorphine | 8mg |
naloxone hydrochloride(UNII: F850569PQR) (naloxone - UNII:36B82AMQ7N) | naloxone | 2mg |
Inactive Ingredients
Ingredient Name | Bryant Ranch Prepack | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. |
---|---|---|---|
ACESULFAME POTASSIUM(23OV73Q5G9) | |||
ANHYDROUS CITRIC ACID(XF417D3PSL) | |||
ANHYDROUS LACTOSE(3SY5LH9PMK) | |||
citric acid monohydrate(2968PHW8QP) | |||
FD&C YELLOW NO. 6(H77VEI93A8) | |||
LACTOSE(J2B2A4N98G) | |||
MAGNESIUM STEARATE(70097M6I30) | |||
MANNITOL(3OWL53L36A) | |||
povidone K30(U725QWY32X) | |||
SODIUM CITRATE(1Q73Q2JULR) | |||
STARCH, CORN(O8232NY3SJ) |
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